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Completed

NCT Number: NCT05375097

Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.

This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed.

Following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported:

Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits

Pre erenumab: Follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the Terveystalo database of those with consent

Post erenumab: Follow-up data after index, from the Terveystalo database of those with consent

Time frames for comparison (sick leaves and visits): One year before index vs. >12 months erenumab after index, One year before index vs. 6-12 months of erenumab after index (patient years), sensitivity analysis

Time frames for comparison (medications): 12 months before index vs. 12 months post follow-up

Controls (triptan treated migraine patients): Corresponding time frames as in cases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients on erenumab treatment ATC: N02CX07
  • Diagnosis of migraine (ICD G43)
  • Consented
  • Occupational healthcare

Exclusion criteria

None

Treatment and study plan

Erenumab

Other

Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses

Primary outcomes

  1. Number of sick leave days (headache)

    Time frame: throughout the study, approximately 2 years

    Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.

Secondary outcomes

  1. Change in number of sick leave days (all cause)

    Time frame: throughout the study, approximately 2 years

    Sick leaves included all registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.

  2. Change in number of healthcare visits (head-ache related)

    Time frame: throughout the study, approximately 2 years

    Number of headache related healthcare visits were reported.

  3. Change in number of healthcare visits (all cause)

    Time frame: throughout the study, approximately 2 years

    Number of healthcare visits were reported.

  4. Medication patterns: Number of patients receiving medications of interest

    Time frame: throughout the study, approximately 2 years

    The number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities Based on Occupational Health Care Registry in Finland: an Observational Retrospective Mirror-image Study (REFI)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 16, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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